GE Healthcare of Chalfont St. Giles, U.K., has cleared one more hurdle in its quest to bring a new brain SPECT radiopharmaceutical called DaTscan to market.
An advisory committee of the U.S. Food and Drug Administration (FDA) on Tuesday voted 11 to 2 to recommend DaTSCAN (ioflupane iodine-123 injection) for FDA clearance.
DaTscan would be used to visualize dopamine transporter distribution within brain striata via SPECT imaging in patients presenting with symptoms or signs suggestive of dopaminergic neurodegeneration and movement disorders, such as Parkinson's disease.
If approved, DaTscan will be the first radiopharmaceutical agent available to detect dopamine transporter distribution within the brain.
Last Friday, the committee sent a memo to GE asking how DaTscan would help diagnose movement disorders. The memo asserted that GE's data for the indication were "unclear" and that the drug may need to be used for a different indication.
The FDA committee also questioned GE's clinical studies in support of the agent, writing in the communiqué that they "are inconsistent with the type of design and conduct usually anticipated" for imaging agents.
On Tuesday, Dr. Don Black, head of research and development for GE Healthcare Medical Diagnostics, said that the committee's approval is a sign those concerns have been alleviated. "I think everyone agreed that there was clear evidence that we are imaging what we said we are imaging," he added. "The question revolved around clinical utility and the vote amongst physicians was that we had met the standard for risk and benefit."
In June, the FDA accepted GE's new drug application (NDA) for DaTscan under the agency's priority review framework, a designation for drugs that potentially offer major advances in treatment or provide treatment where no adequate therapy exists.
Black said the committee's recommendation to approve DaTscan is "very important for the future of molecular imaging agents. This is the first of the molecular imaging agents to come to an advisory committee as a specific agent."
He added that the FDA's actions in granting GE priority review "will have a much broader implication" for other companies seeking to bring molecular imaging agents to market in a more timely manner, whether for oncology indications, to help patients with psychiatric disorders, or for other treatment purposes.
The next action by the FDA on DaTscan is scheduled for September 9.
DaTscan has been available in Europe for the past nine years and has been used by more than 200,000 patients in 32 countries. It also has been administered to approximately 1,000 patients in clinical trials.
Related Reading
GE gets clearance for wide-bore MR scanner, August 11, 2009
FDA panel to review GE DaTSCAN agent, August 10, 2009
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GE Healthcare posts slow Q2, July 17, 2009
GE launches dose-monitoring service, July 16, 2009
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